Biostatistics for Non-Statisticians in Pharma and Medtech

This objective of this seminar is to provide participants with an understanding of:

Basic principles of bio-statistical thinking and methodology

Design and analysis of clinical trials

Techniques for increasing trial efficiency with an eye to reducing costs and increasing chance for success

This seminar is intended for non-statisticians and will furnish participants with tools to understand statistical terminology and methodology in clinical trials. The presentation will focus on actual case studies as they relate to regulatory requirements (FDA, EMA and EU). There is no statistical prerequisite for this seminar.

Attend this seminar to mitigate below risks:

Stat for device submissions for non-statisticians: Not being exposed to the information in this course is likely to lead to inefficient, and perhaps even erroneous, interactions with FDA. This can result in various difficulties such as:

Being asked by FDA to meet harsher criteria than might have been needed, thus reducing Company’s chance for success

Needing a much larger sample size than if the correct approach was used

Specifying inefficient statistical analyses that reduce a trial’s chance for success (for example, running a clinical trial that does not deal efficiently with missing values)

Bio-statistics for non-statisticians: Not being conversant in statistics means that the staff member cannot understand basic concepts in clinical trials such as endpoint selection, trial sample size and trial length. Not knowing how to deal with these issues can cause a company a great deal of damage in terms of inefficient product development (costly in terms of both time and money), inefficient trial design, and erroneous interactions with statisticians. All these can lead to inefficient product development and regulatory submission and even failure:

Almost everyone in the clinical, regulatory and R&D departments should be familiar to one degree or another with bio-statistics. It is the language of regulatory submissions, study design and accounts for much that is presented to FDA (and all regulators) in the clinical study report (CSR). The CSR is the final clinical trial document presented to FDA when submitting a product for approval. Company staff must be at least conversant in bio-statistics so that they can:

Interact intelligently and efficiently with company statisticians, most of whom are subcontracted (i.e. not part of the organization)

Be able to audit the statistician’s decisions

Understand what competitors have done to demonstrate their product works to both regulator and the market

Assist physicians, who are typically clinically oriented, to think in terms of the research needed for bringing a product to market

Efficient Design for non-statisticians:Designing inefficient trials will, at best, cause unnecessary costs in terms of both time and money and, at worst, produce study failure. Additionally, inefficient trial design can cause studies to be rejected by regulators and/or scientific journals. When the former is the case, product failure is almost ensured; when the latter, company’s marketing efforts will be greatly damaged.

Yossi Tal received his Ph.D. from Northwestern University in the U.S., after which he was a statistician at the National Institutes of Health (NIH) in Bethesda, Maryland. Upon returning to his native Israel, he worked at the Statistical Laboratory of the Technion, Israel Institute of Technology. He is currently President of TechnoSTAT (www.technostat.co.il), a bio-statistical consultancy and CRO with clients internationally including Israel, Switzerland, Italy, Sweden, U.S., Finland, Germany, France and elsewhere. Yossi has been involved in many dozens of regulatory submissions to FDA and EU, and has attended numerous meetings at FDA. Yossi is author of Reading between the Numbers: Statistical Thinking in Everyday Life (McGraw-Hill, 1980) and Strategy and Statistics in Clinical Trials (Academic Press, an imprint of Elsevier, 2011). Both of these books are meant for non-statisticians.

Yossi has been presenting seminars on bio-statistics for non-statisticians for almost 20 years. He is a dynamic speaker who consistently receives the highest participant ratings.

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